A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents

Covid19 Vaccine Clinical Trial

Official title:

A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951388
• Other study ID #: CT-COV-22
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: August 2021
• Source: Medigen Vaccine Biologics Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants aged ≥ 12 to < 18 years.

Description:

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center study; the Sponsor will be blinded until the interim analysis. Participants aged ≥ 12 to < 18 years will be enrolled. All eligible participants will be randomized to receive either MVC-COV1901 or placebo in a 6:1 ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: March 21, 2022
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Male or female participant = 12 to < 18 years of age at randomization.

• Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) BMI-for-age at the Screening Visit.

• Female participant must:

1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient);

2. Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the last injection of study intervention. Acceptable forms include:

i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii. Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

• Has a negative pregnancy test

• Participant is willing and able to comply with all required study visits and follow-up required by this protocol.

• Participant has not travelled overseas within 14 days of screening and will not have any oversea traveling throughout the study period.

• Participant and the participant's legal representative must understand the procedures of the study and provide written informed consent.

Exclusion Criteria:

• Pregnant or breast feeding or have plan to become pregnant in 30 days after last administration of study intervention.

• Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.

• Participant previously received a coronavirus vaccine.

• Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.

• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.

• Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of study intervention.

• Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of study intervention.

• Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention

• Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.

• Personal or family (linear or collateral relatives by blood within two generations) history of Guillain-Barré syndrome.

• A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).

• Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.

• Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant.

• Participant with previous known SARS-CoV-1 or 2 infection.

• Participant with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901.

• Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

Related Conditions & MeSH terms

• COVID-19
• Covid19 Vaccine

Intervention

Biological:
• MVC-COV1901(S protein with adjuvant)
Approximately 330 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
• MVC-COV1901(Saline)
Approximately 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital Hsinchu	Hsinchu
Taiwan	Chang-Guang Memorial Hospital Lin-Kou	Taipei
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital-HsinChu	Taipei
Taiwan	National Taiwan University Hosptial	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medigen Vaccine Biologics Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events(AEs) [Safety and Tolerability]	To evaluate the incidence of Adverse Events(AEs) of MVC-COV1901 from Visit 2 (Day 1) to Visit 6 (28 days after the second dose of study intervention) in terms of the number and percentage of participants with the occurrence of: Solicited local AEs (up to 7 days after each dose of study intervention) Solicited systemic AEs (up to 7 days after each dose of study intervention) Unsolicited AEs (up to 28 days after each dose of study intervention) AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs)	Day 1 to 28 days after the second vaccination
Primary	Immunogenicity of MVC-COV1901-1	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers.; The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Geometric mean titers (GMT)	Day 1 to 28 days after the second vaccination
Primary	Immunogenicity of MVC-COV1901-2	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers.; The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Seroconversion rate (SCR)	Day 1 to 28 days after the second vaccination
Primary	Immunogenicity of MVC-COV1901-3	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers.; The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -GMT ratio	Day 1 to 28 days after the second vaccination
Secondary	Incidence of Adverse Events(AEs) [Safety and Tolerability]	To evaluate the Incidence of Adverse Events(AEs) of MVC-COV1901 over the study period in terms of the number and percentage of participants with the occurrence of: >= Grade 3 AE AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs)	Day 1 to 180 days after the second vaccination
Secondary	Immunogenicity of MVC-COV1901-1	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers.; The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT	Day 1 to 180 days after the second vaccination
Secondary	Immunogenicity of MVC-COV1901-2	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers.; The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -SCR	Day 1 to 180 days after the second vaccination
Secondary	Immunogenicity of MVC-COV1901-3	To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers.; The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT ratio	Day 1 to 180 days after the second vaccination